Small incision intraocular lens insertion apparatus

ABSTRACT

An apparatus for inserting a foldable lens into an eye through an incision in the eye comprising: a paddle permanently affixed to the apparatus, and sized and adapted to contact the lens in the unfolded state; an elongated tube including a distally open interior space sized and adapted to receive the paddle in contact with the lens in the folded state, and a distal end portion sized and adapted to be inserted into the eye through the incision, the tube being cooperable with the paddle to fold the lens into the folded state as the lens in contact with the paddle is received through the distal opening into the interior space; and a mechanism to provide relative movement between the paddle and the tube.

BACKGROUND OF THE INVENTION

The present invention relates to an apparatus for inserting a foldableitem, e.g., a foldable intraocular lens and the like, into an eye. Moreparticularly, the invention relates to such an apparatus constructed soas to be distally loaded with the item to be inserted.

An intraocular lens is implanted in the eye, e.g., as a replacement forthe crystalline lens after cataract surgery. Intraocular lenses ofteninclude an optic, and preferably at least one flexible fixation member,e.g., a haptic, that extends from the optic and becomes affixed in theeye to secure the lens in position. The optic normally includes atransparent or optically clear optical lens. Implantation of such lensesinto the eye involves making an incision in the eye. It is advantageous,e.g., to reduce trauma and speed healing, to have the incision sized assmall as possible.

Intraocular lenses are known which are foldable for ease of insertioninto the eye. A substantial number of instruments have been proposed toaid in inserting such a foldable lens in the eye. Many of theseinstruments involve pre-folding the lens before the lens is placed inthe insertion device. While this hand folding allows the lens to beinserted through a relatively small incision, it is time consuming andthe added handling can damage the lens.

Hauser U.S. Pat. No. 4,763,650 discloses an insertion device in which adeformable lens is grasped in its undeformed state in a pair ofdetachable jaws. The jaws are held stationary while a ramp and a thinwalled tube are moved forward. The resulting ramping action causes thejaws to be drawn into the tube and to compress around the lens. The jawsare detached from the remainder of the device as the lens is inserted inthe eye. It would be advantageous to employ a lens insertion systemwhich did not require a ramp and/or which remains in tact throughout thelens insertion process.

Other devices, such as those described in Jampel et al U.S. Pat. No.4,747,404 and in Baccala et al U.S. Pat. No. 4,785,810, use loadingsystems to fold the lens into the insertion apparatus and/or fold thelens through a longitudinally extending slot in the insertion apparatus.Such loading systems are relatively complex, while the relatively largelongitudinally extending slots tend to cause problems in inserting thelens in the eye relative to using a substantially unbroken deliverytube.

SUMMARY OF THE INVENTION

A new apparatus and method useful for surgically inserting a foldableitem, in particular a foldable intraocular lens, into an eye has beendiscovered. This system allows the use of a relatively small incision inthe eye for insertion purposes. In addition, the present apparatus canbe distally loaded with the item at the time of the surgery. This allowsthe surgeon to inspect the lens, in its unfolded state, immediatelybefore inserting the item in the eye. Further, this distal loading ofthe lens is done with a minimum of handling. Thus, the item has reducedsusceptibility to being damaged during the loading process. Further, theloading process is performed very speedily and reliably. The presentapparatus is quite simple and can be produced in a number of forms, aswill be discussed hereinafter, to suit the individual needs of thesurgical application involved and/or the likes and dislikes of thesurgeon. Using the present apparatus, the surgeon can easily andcontrollably place an item into a patient's eye, even into the capsularbag of the patient's eye.

In one broad aspect, the present invention is directed to an apparatusfor inserting a foldable item, in particular a foldable intraocularlens, IOL, into an eye through an incision in the eye. This apparatuscomprises a paddle means sized and adapted to contact the item in theunfolded state; elongated tube means including a distal opening, aninterior space sized and adapted to receive the paddle means in contactwith the item in the folded state, and movement means to provide forrelative movement between the paddle means and the tube means. Theelongated tube means includes a distal end portion sized and adapted tobe inserted into the eye through the incision. The tube means and thepaddle means cooperate to fold the item into the folded state as theitem, carried by the paddle means, is received through the distalopening into the interior space. The present apparatus is usable withoutrequiring a ramp assist, as in the above noted Hauser patent.

In one embodiment, the paddle means is permanently affixed to theapparatus. In this manner the present system is further distinguishedfrom the Hauser patent noted above, in which the jaws of the system weredetachable during the surgery.

In another particularly useful embodiment, the movement means acts toprovide movement of the paddle means relative to the tube means. Thisembodiment provides a still further distinction from the above notedHauser patent in which the thin wall tube and ramp are moved forwardwhile the jaws are held stationary. In this embodiment the paddle meansand the unfolded item are moved through the distal opening of the tubemeans into the interior space.

In an additional particularly useful embodiment, the paddle meansincludes a flexible element which is sized to carry the item in theunfolded state. This flexible element is adapted to be received in theinterior space of the elongated tube means. Preferably, a singlegenerally tear drop or pear-shaped flexible element is used. Thegenerally tear drop or pear-shaped flexible element is generally roundedat its distal end and narrows toward its proximal end. This embodimenthas been found especially useful in that the flexible element actuallywraps around the item as it is folded. An additional advantage of such aflexible element is that when the item, in particular an IOL, includesat least one flexible fixation member, the item can be oriented withrespect to the flexible element so that the fixation member is generallyparallel to or perpendicular to the longitudinal axis of the elongatedtube. This feature allows the surgeon substantial flexibility ininserting the item into the patient's eye. Although the flexible elementmay be of any suitable size, the width of the flexible element, i.e.,the maximum dimension of the flexible element substantiallyperpendicular to the longitudinal axis of the elongated tube, ispreferably in the range of about 4 mm to about 9 mm. Smaller flexibleelements are particularly useful in the present small incision insertionapparatus. Also, smaller flexible elements have been found to be veryeffective in cooperating with the tube means to fold the item to beinserted, and are more readily controlled and positioned in the eyeduring the insertion procedure, relative to larger flexible elements.For example, the use of a relatively small flexible element allows anIOL to be placed in the capsular bag of the eye. Thus, the width of theflexible element is more preferably less than about 8.5 mm, and stillmore preferably in the range of about 5.5 mm to about 7.5 mm. Excellentresults are achieved when the flexible element has a width in the rangeof about 6.5 mm to about 7 mm. The length of the flexible element, i.e.,the maximum dimension of the flexible element substantially parallel tothe longitudinal axis of the elongated tube, is preferably in the rangeof about 9.5 mm to about 11 mm.

The tube means may further include a slot extending proximally from thedistal opening and outwardly from the interior space. This slot, whichpreferably extends through the tube means, is sized and adapted so thatwhen the item, in particular an IOL, is in the interior space theflexible fixation member or members of the item extend into, andpreferably protrude from, the slot. The slot is preferably notsufficiently wide to allow any portion of the foldable body of the item,e.g., the optic of an IOL, to extend into the slot. This feature reducesthe chances of damaging the flexible fixation members while, at the sametime, maintaining a substantially smooth and continuous outer peripheralsurface of the tube means to allow for relatively easy insertion throughthe incision in the eye.

At least a part of the paddle means, and in particular the flexibleelement, is preferably transparent. This feature allows the surgeonmaximum opportunity to view the item as it is being loaded into theinsertion apparatus. One particularly useful class of materials fromwhich the paddle means can be produced are polymeric materials.Especially preferred materials from which the flexible element of thepaddle means can be constructed are the polyesters, in particularstatically charged polyesters, for example the polyester sold byCadillac Plastics under the trademark Mylar.

The tube means may include a distal end which is substantiallyperpendicular to the longitudinal axis of the tube means. However, inone embodiment it is preferred that this distal end is beveled. That is,at least a portion of this distal end is oriented at an angle other thanperpendicular to the longitudinal axis of the tube means. Such bevelingmay be of any suitable configuration which allows for easier insertionof the tube means into the eye, relative to a tube means with anunbeveled distal end. The tube means preferably has a substantiallyelliptical outer cross-section perpendicular to its longitudinal axis.These features provide for increased ease in inserting the tube meansthrough the incision in the eye.

The interior space in the tube means is preferably substantially uniformin cross sectional area (perpendicular to the longitudinal axis of thetube means) along its length. In order to provide for increased ease inloading the item into the apparatus and in inserting the item into theeye, it is preferred that the axial wall of the interior space berifled, e.g., include one or more helical ridges.

The outer peripheral wall of the tube means may be smooth to allow forrelative ease in inserting the tube through the incision in the eye.However, another factor must be considered in designing the tube means.The tube means must have sufficient strength to cooperate with thepaddle means to fold the item as the item is loaded into the interiorspace. At the same time, the tube means must have a sufficiently smallcross sectional profile (perpendicular to the longitudinal axis of thetube means) to allow the tube means to be inserted through the smallincision in the eye. In one embodiment, the outer peripheral surface ofthe tube means is ribbed to provide additional strength to the tubemeans. The radial thickness of the tube means between the axial wall ofthe interior space and the outer peripheral surface of the tube means ispreferably at least about 0.051 mm,, and more preferably no greater thanabout 0.381 mm. Such dimension has been found to provide sufficientstrength when the tube means is made of one or more metals, inparticular stainless steel, such as the 300 series stainless steel,e.g., 303, 304 and 316 stainless steels. In any event, the material ormaterials used to construct the present insertion apparatus, and inparticular those components of the present apparatus which are actuallyinserted into the eye, should be such as to cause no undue damage to theeye or patient being treated.

The movement means referred to above may act to move the paddle meansrelative to the tube means or may act to move the tube means relative tothe paddle means. Thus, one surgeon may prefer to have the paddle meansmove relative to the tube means while another surgeon may wish to havethe tube means move relative to the paddle means. The present system canbe structured to operate in either one of these two modes.

Although the present movement means may be automatically operable, suchfeature can add costly and unnecessary sophistication to the presentapparatus. For this reason, it is preferred that the movement means bemanually operable. In one embodiment, the movement means includes amechanism capable of being activated by sliding relative to the paddlemeans or the tube means. This mechanism may be located at or near theproximal end of the apparatus or, alternately and preferably, away fromthe proximal end of the apparatus. For example, the mechanism mayinvolve a plunger type device extending from the proximal end of theapparatus and connected to either the paddle means or the tube means.Alternately and preferably, the mechanism may include a slidable stem orslider located on the side, e.g., protruding through a slot andextending outwardly from the outer peripheral wall or surface, of thehousing means, in particular toward the distal end portion of thehousing means, of the apparatus. This stem is connected to either thepaddle means or the tube means and, by sliding along a length of thehousing means, causes either the paddle means or the tube means to move.

The present invention further includes a method for inserting a foldableitem into an eye. This method comprises placing the item in the unfoldedstate in contact with a paddle means, passing the item in contact withthe paddle means through a distal opening into an interior space of atube means, thereby folding the lens in contact with the paddle means;inserting the tube means into the eye; withdrawing the item in contactwith the paddle means from the interior space through the distalopening; and withdrawing the paddle means and tube means from the eye.The item is released by or separated from the paddle means prior to thepaddle means and tube means being withdrawn from the eye. The item, inits unfolded state, remains in the eye. This method can be performed,with various modifications, with the various embodiments of theinsertion apparatus set forth herein. An incision is made in the eyeprior to inserting the tube means into the eye. Once the tube means andpaddle means are withdrawn from the eye the incision can be mended.

Another aspect of the present invention involves an apparatus and methoduseful for loading a foldable item, in particular a foldable IOL, forexample, into the present insertion apparatus. This loading system isrelatively simple, very reliable and allows for visual inspection of theitem just prior to loading the item.

In one embodiment, the present loading apparatus comprises an elongatedfirst element having a distal end portion and a proximal end portion,and an elongated second element having a distal end portion in the formof a rod element and a proximal end portion. A platform member isaffixed to the first element at or near the distal end portion of thefirst element. This platform member has a surface sized and adapted tocarry the item, in its unfolded state. The distal end portions of thefirst and second elements are joined together in such a manner that thedistal end portions of these elements are movable toward or away fromeach other, e.g., in a "forceps-like" action. The loading apparatus ispreferably structured to be biased to keep the distal end portions ofthe elements apart. This biasing is preferably overcome using manualforce. The first and second elements are movable relative to each otherto allow the rod element to contact the item being carried by thesurface to hold the item in place on the surface. The rod elementpreferably has a dimension generally perpendicular to this longitudinalaxis of the first element which is smaller than the maximum dimension ofthe surface of the platform generally perpendicular to the longitudinalaxis. This feature allows the surgeon to visually inspect the item beingheld between the surface and the rod element.

This loading apparatus may be used to load an item into the presentinsertion apparatus. Thus, the item, in its unfolded state, to be loadedis placed on a surface. The item is held in place on the surface with arod element in contact with the item. When it is desired to load theitem into the insertion apparatus, the rod element is moved out ofcontact with the item being carried by the surface, and the paddle meansof the insertion apparatus is positioned in contact with the item on thesurface. The paddle means is drawn into the tube means, as describedherein, and the item is ready to be inserted into the eye.

The foldable intraocular lenses insertable in the eye using the presentsystem may be of any configuration suitable to perform the desiredfunction in the eye. Such lenses often include a lens body or opticwhich has optical properties in the eye. Such lens body may have anysuitable configuration, provided that it is foldable as set forthherein. In many instances the lens body is generally circular. However,other configurations are also useful. In addition, the intraocularlenses may, and preferably do, include at least one flexible fixationmember which is secured or attached to the optic. This flexible fixationmember acts to fix the intraocular lens in position in the eye. Examplesof flexible fixation members include flexible haptics which arepreferably radially resilient and extend outwardly from the periphery ofthe lens body. Specific examples of such flexible haptics include thosecommonly known as J-loops and C-loops. Such haptics engage appropriatecircumferential eye tissue adjacent the iris or within the capsular bagto fix the lens in position in the eye. A very useful intraocular lensincludes a plurality of, especially two, such flexible haptics.

As used herein, the terms "deformable" or "foldable" means that the itemor IOL, and in particular the lens body or optic, can be temporarilyreshaped so as to pass through a smaller, e.g., in terms of diameter,incision relative to the incision required if the lens was nottemporarily reshaped.

The lens body may be made of any suitable material such aspolymethylmethacrylate, silicone, hydrogel or other well known materialsfor foldable lens construction. Preferably, the lens body also includesan ultraviolet light absorber. The flexible fixation member or membersmay be made of any suitable material such as polymethylmethacrylate,prolene, polypropylene, nylon, silicone or other materials suitable forimplantation into the eye.

These and other aspects and advantages of the present invention are setforth in the following detailed description and claims, particularlywhen considered in conjunction with the accompanying drawings in whichlike parts bear like reference numerals.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of one embodiment of the present lensinsertion apparatus.

FIG. 2 is a cross-sectional view taken along line 3--3 of FIG. 1 showingthe paddle fully retracted.

FIG. 3 is a fragmentary cross-sectional view taken along line 3--3 ofFIG. 1.

FIG. 4 is a cross-sectional side view showing an alternate embodiment tothat in FIGS. 1, 2 and 3 with the tube fully retracted.

FIG. 5 is a fragmentary cross-sectional side view showing the alternateembodiment shown in FIG. 4 with the tube fully extended.

FIG. 6 is a perspective view of another embodiment of the present lensinsertion apparatus.

FIG. 7 is a cross-sectional view taken along line 7-7 of FIG. 6 showingthe paddle fully retracted.

FIG. 8 is a cross-sectional side view showing a further alternateembodiment of the present lens insertion apparatus.

FIG. 9 is a diagrammatic view showing an intraocular lens being insertedinto an eye in accordance with the present invention.

FIG. 10 is a perspective view of an embodiment of the present lensloading apparatus.

FIG. 11 is a fragmentary side elevation view showing the lens loadingapparatus shown in FIG. 10 in use with the lens insertion apparatusshown in FIG. 1.

FIG. 12 is a fragmentary bottom view of the paddle and tube of theinsertion apparatus shown in FIG. 1 showing an intraocular lens about tobe drawn into the tube.

FIG. 13 is a cross-sectional view taken along line 13--13 of FIG. 12.

FIG. 14 is a cross-sectional view taken along line 14--14 of FIG. 12after the lens is drawn into the tube.

FIG. 15 is a fragmentary bottom elevation view showing another alternateembodiment of the present lens insertion apparatus.

FIG. 16 is a fragmentary side elevation view, partly in cross-section,showing a still further alternate embodiment of the present lensinsertion apparatus.

FIG. 17 is a fragmentary side elevation view showing yet anotheralternate embodiment of the present lens insertion apparatus.

FIG. 18 is a fragmentary perspective view showing an additionalembodiment of the present lens insertion apparatus.

FIG. 19 is a cross-sectional view taken along line 19--19 in FIG. 18after the lens has been drawn into the tube.

FIG. 20 is a cross-sectional view taken along line 20--20 of FIG. 7.

DETAILED DESCRIPTION OF THE DRAWINGS

FIGS. 1, 2 and 3 show, in general, a lens insertion apparatus 10, whichincludes a flexible paddle 12, a distally open hollow tube 14, a handleor housing 16, a longitudinally extending slot 18 extending to a distalend of the housing 16 as shown in FIG. 3 and an outwardly extendingslider 20. Tube 14 has an open distal end 22 which defines a distalopening 23 that leads to interior space 24, partially defined by axialwall 26. Tube 14 and interior space 24 have generally ellipticalcross-sections perpendicular to the longitudinal axis 27 of apparatus10. Housing 16 is hollow with an inner space 28 defined by distal endelement 30, a peripheral wall 32 and a proximal end wall 34. Tube 14 ismade of 304 stainless steel and has a solid wall thickness,perpendicular to the longitudinal axis 27, of at least about 0.051 mm,in particular about 0.115 mm.

The lens insertion apparatus 10 is structured so that slider orprotruding portion 20 is integral with a plug or body 36, which is sizedand adapted to move axially in inner space 28. Plug 36 includes anaxially extending through hole 38 into which is secured, e.g., usingadhesives or other conventional means of securement, the proximal end 39of elongated element 40. The distal end of elongated element 40 issecured to flexible paddle 12, which paddle has a generally teardrop-like configuration with a width (in the unfolded state) of about 7mm and a length of about 10 mm and is made of transparent polyester.Tube 14 extends into an axially extending opening of the distal endelement 30 (FIG. 3) and is secured to distal end element 30.

Flexible paddle 12 is movable relative to tube 14 of insertion apparatus10 as follows. With slider 20 in a position as shown in FIG. 2, flexiblepaddle 12 is folded (as will be discussed hereinafter) and entirelywithin interior space 24 of tube 14. As slider 20 is moved distallywithin slot 18 toward distal end element 30, flexible paddle 12 moves(relative to tube 14) toward distal opening 23. As slider 20 is moveddistally so that plug 36 contacts distal end element 30 (which contactacts as a stop to the distal movement of slider 20, as in FIG. 3),flexible paddle 12 is entirely outside interior space 24 of tube 14.When it is desired to retract flexible paddle 12 into interior space 24,slider 20 is simply moved proximally in slot 18 until flexible paddle 12is so retracted. The proximal end 42 of slot 18 comes in contact withslider 20 as slider 20 is moved proximally and acts as a stop to suchproximal movement.

An alternate lens insertion apparatus, designated as 110, is shown inFIGS. 4 and 5. Except as expressly set forth below, the apparatus 110 isstructured and functions substantially similarly to apparatus 10.Components of apparatus 110 which correspond to components of apparatus10 are given corresponding reference numerals increased by 100.

Referring now to FIGS. 4 and 5, apparatus 110 includes a stationary plug44 which is secured in place in inner space 128. Stationary plug 44includes an axially extending through hole 46 into which is secured theproximal end 139 of elongated element 140, which is longer thanelongated element 40. In this manner flexible paddle 112 is heldstationary with respect to housing 116. Slider 120 is integral withsliding plug 47 which includes a relatively large diameter, axiallyextending through hole 48. The proximal end of tube 114, which is longerthan tube 14, is secured in hole 48, and is not secured to distal endelement 130. Thus, tube 114 is movable with slider 120 relative tohousing 116. To illustrate, with slider 120 positioned fully proximallyin slot 118, as shown in FIG. 4, tube 114 is fully retracted andflexible paddle 112 is fully outside the interior space 124 of tube 114.By moving slider 120 distally to a position shown in FIG. 5, tube 114moves and captures stationary flexible paddle 112 in interior space 124through distal opening 123.

FIGS. 6, 7 and 20 illustrate another lens insertion apparatus, showngenerally at 210. Except as expressly set forth below, lens insertionapparatus 210 is structured and functions substantially similarly toapparatus 10, as described herein. Components of apparatus 210 whichcorrespond to components of apparatus 10 are given correspondingreference numerals increased by 200.

The primary difference between the two apparatus 10 and 210 is in thestructure to move the flexible paddle relative to the tube. In apparatus210, a proximally open housing 49 is provided which includes aperipheral wall 50 secured at its distal end to distal end element 230.Peripheral wall 50, together with distal end element 230, defines innerspace 51. Finger rings 52 and 53 extend radially from opposing sides ofperipheral wall 50. A plunger element 54 is slidably fitted into innerspace 51 and extends proximally of housing 49. The proximal end ofplunger element 54 is provided with a radially extending thumb ring 55,which facilitates manually moving, e.g., using only one hand, plungerelement 54 in and out of inner space 51, as desired. The distal end ofplunger element 54 includes an axially extending hole 56 into which issecured the proximal end of elongated element 240. One additionalfeature of apparatus 210 is axial wall 57 of tube 214. Axial wall 57 isrifled, as illustrated in FIG. 20, to provide for ease in moving paddle212 relative to tube 214.

Plunger element 54 is pulled proximally of housing 49, as shown in FIG.7 to retract flexible paddle 212 into interior space 224. By pushingplunger element 54 distally, flexible paddle 212 extends fully out ofdistal opening 223 of tube 214. As plunger element 54 is moved distallyrelative to housing 49, plunger element 54 comes into contact withdistal end element 230 and acts as a stop to this distal movement.

FIG. 8 illustrates a further alternate lens insertion apparatus, showngenerally at 310. Except as expressly set forth below, lens insertionapparatus 310 is structured and functions substantially similarly toapparatus 210. Components of apparatus 310 which correspond tocomponents of apparatus 210 are given corresponding reference numeralsincreased by 100.

The primary difference between the two apparatus 210 and 310 is that inapparatus 210 the flexible paddle 212 is movable and the tube 214 isstationary relative to housing 49, whereas in apparatus 310 the tube 314is movable and the flexible paddle 312 is stationary relative to housing60. Apparatus 310 has an elongated housing 60 including a peripheralwall 61. An axially extending inner space 62 is defined by distal endelement 330, peripheral wall 61 and the proximal end wall 63 of housing60. Two axially extending slots 64 and 65 are positioned in opposingsides of peripheral wall 61. A stationary plug 66 is secured in toperipheral wall 61 toward the proximal end of inner space 62. Stationaryplug 66 includes an axially extending through hole 67 into which issecured the proximal end of elongated element 340, which is longer thanelongated element 240. In this manner, paddle 312 is held stationaryrelative to housing 60.

A slidable plug 68 is positioned in inner space 62, and includes arelatively large axially extending through hole 69 and two radiallyextending finger rings 70 and 71 which extend out of slots 64 and 65,respectively. The proximal end of tube 314 is secured in hole 69. Tube314 is longer than tube 214 and is not secured to distal end portion330. A thumb ring 72 is secured to, and extends proximally from,proximal end wall 63. As shown in FIG. 8, finger rings 70 and 71 andthumb ring 72 are substantially coplanar. Finger rings 70 and 71 andthumb ring 72 facilitate manually moving, e.g., using only one hand,slidable plug 68 (and tube 314) relative to housing 60 (and flexiblepaddle 312).

As shown in FIG. 8, slidable plug 68 is moved to the distal end of slots64 and 65 where its movement is stopped. In this configuration, paddle312 is totally within interior space 324 of tube 314. As slidable plug68 is moved toward the proximal ends of slots 64 and 65, where itsmovement is again stopped, tube 314 retracts and paddle 312 passesthrough distal opening 323 and is totally outside interior space 324.

Before describing in detail the functioning of the insertion apparatusshown in FIGS. 1 to 8, reference is made to a lens loading apparatus,shown generally as 75, in FIG. 10. Loading apparatus 75 is aforceps-like arrangement including a first elongated element 76 and asecond elongated element 77, which are joined together at theirrespective proximal ends 78 and 79. The distal end of first element 76includes a planar surface 80 which is oriented to be substantially flatwhen apparatus 75 is laid on a flat surface with only first element 76touching this flat surface. Planar surface 80 is sized and adapted tocarry foldable intraocular lens 85, which includes optic 86 and firstand second flexible haptics 87 and 88. A relatively narrow, rod-likeextension 89 is secured to second element 77 and extends distally ofsecond element 77. Extension 89 is more narrow (in a directionperpendicular to planar surface 80 and to the longitudinal axis 81 offirst element 76) than planar surface 80 to allow visual inspection oflens 85 as it is held on planar surface 80 by extension 89.

The general functioning of loading apparatus 75 is described withreference to the insertion apparatus 10, in FIGS. 1, 2 and 3. However,it will be apparent that such loading apparatus 75 may be used in asubstantially similar manner with each of the other insertion apparatusdescribed herein, and all such uses are within the scope of the presentinvention.

Referring now to FIGS. 10, 11, 12, 13 and 14, loading device 75functions as follows. The intraocular lens 85 is positioned with optic86 on planar surface 80 and the first and second haptics 87 and 88oriented substantially parallel to the longitudinal axis of the firstelement 76. If desired, intraocular lens 85 can be positioned so thatfirst and second haptics 87 and 88 are oriented substantiallyperpendicular to the longitudinal axis 81 of the first element 76. Firstand second elements 76 and 77 are squeezed together so that extension 89comes into contact with optic 86. In this manner lens 85 is securedagainst movement.

With lens 85 held between planar surface 80 and extension 89, thesurgeon may visually inspect that the lens is properly oriented. Aftersuch inspection, extension 89 is moved out of contact with lens 85 andinsertion apparatus 10 is positioned so that the flexible paddle 12 ison top of and in contact with lens 85 carried by planar surface 80, asshown in FIG. 11. FIGS. 12 and 13 show the positioning of lens 85relative to paddle 12 as in FIG. 11, without showing planar surface 80.

As slider 20 is moved toward the proximal end 42 of slot 18, paddle 12and lens 85 move through distal opening 23 of tube 14 into interiorspace 24. As this movement occurs, paddle 12 and tube 14 cooperate tofold optic 86 so that when both paddle 12 and optic 86 are entirely ininterior space 24, optic 86 is as shown in FIG. 14. In this position,lens 85 is loaded into insertion apparatus 10 and loading apparatus 75has performed its function.

Referring now to FIG. 9, insertion apparatus 10 functions as follows.The lens 85 is to be placed in eye 92 into an area formerly occupied bythe natural lens of the eye. FIG. 9 shows the sclera 93 of the eye 92having an incision through which the distal portion of insertionapparatus 10 may be inserted. Specifically, with paddle 12 and optic 86entirely within interior space 24, as shown in FIG. 14, an incision ismade in sclera 93 and the distal end of tube 14 is inserted into thisincision. The tube 14 is manipulated within eye 92 until it ispositioned so that lens 85 can be properly positioned in eye 92, e.g.,in the anterior chamber, the posterior chamber, the capsular bag 94, orin the sulcus, after being released from paddle 12. Thus, the surgeon isable to controllably position tube 14 before releasing lens 85. Also,since slider 20 is movable only a limited distance distally, the surgeonis able to precisely place the lens 85 without concern for "overshooting" the target area. Once tube 14 is so positioned, slider 20 ismoved distally in slot 18 so that paddle 12 and optic 86 pass out ofinterior space 24 through distal opening 22. As paddle 12 and optic 86unfold, lens 85 separates from, or is released by, paddle 12 and remainsin eye 92. The relatively small size of flexible paddle 12 provides forincreased flexibility in positioning lens 85 in eye 92. In other words,relatively small flexible paddle 12 is able to be passed into variouspositions in eye 92, e.g., in or near capsular bag 94, which are notpractical or even possible using a bigger paddle. After flexible paddle12 is retracted into tube 14, insertion apparatus 10 is withdrawn fromthe eye 92. If needed, the position of lens 85 can be adjusted by asmall, bent needle, or similar tool inserted into the same incision.

Once the lens 85 is properly placed in eye 92 and insertion apparatus 10is withdrawn from eye 92, the incision in the sclera 93 is mended, e.g.,using conventional techniques. After use, insertion apparatus 10 ispreferably disposed of.

Insertion apparatus 110, 210 and 310 function in a manner substantiallysimilar to that described with regard to insertion apparatus 10. Onedifference is that paddle 12 is movable relative to housing 16 inapparatus 10, whereas in apparatus 110 and 310 tubes 114 and 314 aremovable relative to housings 116 and 60, respectively. Also, inapparatus 210, paddle 212 is moved by moving plunger element 54proximally or distally relative to housing 49, while in apparatus 310,tube 314 is moved by moving slidable plug 68 proximally or distally inslots 64 and 65.

Referring now to FIG. 15, another alternate lens insertion apparatus isshown generally at 410. Except as expressly set forth below, lensinsertion apparatus 410 is structured and functions substantiallysimilarly to apparatus 10. Components of apparatus 410 which correspondto components of apparatus 10 are given corresponding reference numeralsincreased by 400.

The primary difference between apparatus 410 and apparatus 10 is thattube 414 includes a single distally open, axially extending through slot95. Apparatus 410 is particularly applicable when it is desired toorient lens 85 relative to paddle 412 so that the haptics 87 and 88 aregenerally perpendicular to the longitudinal axis 427 of apparatus 410,as shown in FIG. 15. As lens 85 is drawn into the interior space of tube414, optic 86 is folded and haptics 87 and 88 extend into and protrudeout of slot 95. Slot 95 is wide enough to allow haptics to extend intoand protrude from it, while being sufficiently narrow so as not tosubstantially disrupt the outer surface of the tube 414. This relativelynarrow through slot 95 allows the tube 414 to be easily inserted intothe eye 92 while still protecting the haptics 87 and 88 from damage.

Referring now to FIG. 16, a still further alternate lens insertionapparatus shown generally at 510. Except as expressly set forth below,lens insertion apparatus 510 is structured and functions substantiallysimilarly to apparatus 10. Components of apparatus 510 which correspondto components of apparatus 10 are given corresponding reference numeralsincreased by 500.

The primary difference between apparatus 510 and apparatus 10 is thesubstitution of ribbed tube 96 for tube 14. Ribbed tube 96 is made of apolymeric material while tube 14 is made of stainless steel. Ribbed tube96 includes a series of strength enhancing ribs 97. The wall thickness(perpendicular to the longitudinal axis 527) ranges from 0.128 mm to0.256 mm. Ribbed tube 96 is sufficiently strong to cooperate, withoutstructural failure, with paddle 512 to fold optic 86 as the optic isdrawn through distal opening 103 in distal end 104 of ribbed tube 96into the interior space 98 of ribbed tube 96. Interior space 98 andribbed tube 96 have generally elliptical cross-sections perpendicular tolongitudinal axis 527. The ribbed tube allows relatively low strengthpolymeric materials to be used as tube construction materials.

Referring now to FIG. 17, yet another alternate lens insertion apparatusis shown generally at 610. Except as expressly set forth below, lensinsertion apparatus 610 is structured and functions substantiallysimilarly to apparatus 10. Components of apparatus 610 which correspondto components of apparatus 10 are given corresponding reference numeralsincreased by 600.

The primary difference between apparatus 610 and apparatus 10 is thatthe distal end 105 of tube 614 is beveled. This facilitates and/or makeseasier the insertion of tube 614 into the eye.

Referring now to FIGS. 18 and 19, an additional lens insertion apparatusis shown generally at 710. Except as expressly set forth below, lensinsertion apparatus 710 is structured and functions substantiallysimilarly to apparatus 10. Components of apparatus 710 which correspondto components of apparatus 10 are given corresponding reference numeralsincreased by 700.

The primary difference between apparatus 710 and apparatus 10 is thatflexible paddle 12 is replaced by a folding assembly, shown generally as99. Folding assembly 99 includes a first flexible element 100, a secondflexible element 101 and a rod element 102, each of which is secured toelongated element 740. First and second flexible elements 100 and 101are transparent and can be made of materials from which flexible paddle12 is made. Folding assembly 99 is structured so that each of the firstand second flexible elements 100 and 101 and the rod element 102separate, as shown in FIG. 18, when folding assembly 99 extends distallyfrom tube 714.

With folding assembly 99 positioned as shown in FIG. 18, lens 85 isplaced (e.g., using loading apparatus 75) between first and secondflexible elements 100 and 101 and rod element 102. Folding assembly 99is then drawn into tube 714. This causes tube 714 and folding assembly99 to cooperate to fold optic 86, as shown in FIG. 19. With lens 85loaded in apparatus 710, tube 714 is inserted into an incision in theeye and elongated element 740 is moved distally to move folding assembly99 out of tube 714. This causes lens 85 to be released from apparatus710, which can then be removed from the eye.

The various individual features illustrated in one or more specificembodiments described herein can be used alone or together in otherembodiments and all such other embodiments are within the scope of thepresent invention.

While this invention has been described with respect to various specificexamples and embodiments, it is to be understood that the invention isnot limited thereto and that it can be variously practiced within thescope of the following claims.

What is claimed is:
 1. An apparatus for inserting a foldable intraocularlens into an eye comprising:a handle including a peripheral wall and anend element attached to the peripheral wall adjacent one end of theperipheral wall, said handle having an elongated chamber, said endelement having an axially extending opening extending through the endelement; a tube having an axially extending passage extending throughthe tube; a portion of said tube being received in the axially extendingopening of the end element; means for attaching the tube to the endelement with said portion of the tube being in said axially extendingopening of the end element; said peripheral wall having a distal end anda slot in the peripheral wall leading to said chamber and extending tothe distal end; an actuator having a body movable longitudinally in saidchamber and a protruding portion which extends from the body through theslot, the protruding portion and the body being unitary; a flexiblepaddle; and an elongated element extending through the passage of thetube and coupling the paddle to the actuator.
 2. An apparatus as definedin claim 1 wherein the tube has a tube wall defining the passage of thetube and the thickness of the tube wall is a least about 0.051 mm and nogreater than about 0.381 mm.
 3. An apparatus as defined in claim 1wherein the tube is metal.
 4. The apparatus of claim 3 wherein saidmetal is stainless steel.
 5. The apparatus of claim 3 wherein said metalis selected from the group consisting of the 300 series stainlesssteels.
 6. The apparatus of claim 1 wherein said tube further includes adistal end which is beveled.
 7. The apparatus of claim 1 wherein saidtube has an axial wall which is rifled.
 8. The apparatus of claim 1wherein said tube has a substantially elliptical cross-sectionperpendicular to the longitudinal axis of said apparatus.
 9. Theapparatus of claim 1 wherein said paddle has a width in the range ofabout 4 mm to about 9 mm.
 10. The apparatus of claim 9 wherein saidpaddle has a length in the range of about 9.5 mm to about 11 mm.
 11. Theapparatus of claim 1 wherein said paddle includes a plurality ofelements which come into closer relation to each other as said paddle isreceived by said tube.
 12. The apparatus of claim 1 wherein at least apart of said paddle is transparent.
 13. A method comprising:supportingan intraocular lens on a supporting surface; positioning a lensinsertion apparatus having a flexible paddle with the paddle being abovethe intraocular lens; and with the paddle above the intraocular lens,retracting the flexible paddle within a tube of the lens insertionapparatus to fold the paddle about the intraocular lens to fold theintraocular lens and to retract the intraocular lens into the tube. 14.A method as defined in claim 13 wherein said step of supporting iscarried out with forceps.
 15. A method as defined in claim 13 includinginserting the tube through an incision into the eye and advancing thepaddle out of the tube to insert the foldable lens into the eye.